BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    O'NEIL URINARY CATHETER INTRODUCER

    K Number: K854443 · Decision Jan 8, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    O'NEIL URINARY CATHETER INTRODUCER
    K Number
    K854443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Pennine Medical , Ltd.
    Date Received
    November 5, 1985
    Decision Date
    January 8, 1986
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOD Catheter, Urological

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    Other Clearances by Pennine Medical , Ltd.

    K Number Device Name
    K852859 PENNINE CONNECTING TUBING
    K852081 PENNINE OXYGEN LINK TUBING
    K844874 PENNINE LINK YANKAUERS
    K844876 PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,
    K852079 PENNINE DERBY YANKAUER
    K852080 PENNINE SUCTION CATHETERS
    K844873 PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4